FDAFDA · Alimentos y medicamentos·N.º oficial Z-0697-2013
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.
Publicado el 23 de enero de 2013 · Inicio del retiro: 7 de noviembre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report, however the correct value should have read 28.4 ng/mL.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- IDS (Immunodiagnostic Systems Ltd.)
- Distribuidor
- US Nationwide Distribution
- Lote
- Lot # 17628
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United Kingdom
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